Barnett International's Core Curriculum courses are comprehensive role-based clinical research training programs designed to provide industry professionals with hands-on training in a dynamic virtual setting. Held four times a year during our “Clinical Research Training Weeks,” courses offer clinical research-focused, performance-based training and core competency development.
FDA Pre-Approval Inspection Readiness: Clinical Investigators
Upcoming Courses
There is often fear and a mystique surrounding the process of an FDA site inspection. This workshop will include insights from a former FDA medical officer on the importance of Good Clinical Practices (GCPs) to help ensure sites are prepared for the FDA. Your instructor will show learners exactly what the FDA is looking for during a site inspection, and why these inspections are critical to both the drug/device approval process. This workshop will include presentations, discussions, and problem-solving using case studies applicable to both drug and device studies. Exercises are designed to prepare you for the FDA’s arrival, anticipate FDA issues and concerns, and ensure success. Learners are encouraged to bring their questions and join in interactive discussions. Together we will de-mystify the process of FDA audits and help you learn how to ready your site for the FDA.
- Conclude investigational sites are better prepared for GCP/FDA inspections
- Anticipate FDA GCP expectations for both drugs and medical devices
- Recognize sponsor/company/investigator responsibilities applicable to FDA submission
- Apply basic concepts to assess whether companies/sponsors follow current FDA risk-based monitoring/auditing guidances
- How to think like a regulator
- Clinical Research Professionals
- Clinical Research Coordinators
- Clinical Research Associates
- Investigators and Site Personnel
- IRB/Ethic Committee Members
- Project Managers
- Quality Assurance Personnel
- Regulatory Affairs Professionals
- Auditors/Monitors
The course will be led by one of the following instructors:
Jerri Barden Perkins, M.D.
Click here for complete trainer biographies
Day 1: 8:30 a.m. – 5:00 p.m.
- How to Prepare Your Site for an FDA Inspector
- Fraud Detection: How Does FDA find Fraud?
- Investigator/Sponsor Responsibility for Clinical Investigation including 1572
- Hands-on Exercise: Mock FDA Audit Role Play
Day 2: 8:30 a.m. – 5:00 p.m.
- Risk-Based Monitoring/Auditing
- 483s and FDA Warning Letters: What can be Learned?
- Current FDA Actions Regarding IRB/Ethics Responsibilities
- Errors in GCP and How to Prevent Clinical Nightmares
- Team Review of Warning Letters with group discussion
- Team Role Play in Mock Audit
- Questions for each participant to be answered independently with group discussion on answers
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
Click here for our seminar cancellation policy
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE# 0778-0000-15-028-L01-P. Released 2/15.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.
